We are here, every step of the way with our turn key Pharmacovigilance Solutions
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Why We Are The Best
4C is run and managed by medical doctors who have evolved from the Industry of Clinical Research and Pharmacovigilance Solutions or Pharmacovigilance (PV) Outsourcing. With handpicked best talents from the industry and trained them on robust 4C curriculum to deliver best in class service and experience to our Small, Medium and Large pharma clients. 4C excels in providing end to end effective monitoring of safety and efficacy for Drugs, Devices, Biologics & Nutraceutical.
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Case Intake and Monitoring
4C is equipped to support adverse events report of animal health data to the EMA and all EU Competent Authorities using the EUVeterinary guidelines as well as HL7 complaint system required by the FDA’s Center for Veterinary Medicines and as defined by the VICH.
Veterinary pharmacovigilance is defined in Article 73 of Directive 2001/82/EC covers not only the safety aspects in animals and in humans related to veterinary medicinal products, but also other aspects of post-authorization surveillance. The system also considers any available information arising from the use of veterinary medicinal products, such as:
- Lack of expected efficacy of veterinary medicinal products
- Adverse reaction reports related to off-label use
- Reported violations of approved residue limits, possibly leading to investigations of the validity of the withdrawal period
- Potential environmental Problems